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Pharmacy cannot use seller shield defense in health care liability case.

 

When a complaint asserts a health care liability  (formerly known as “medical malpractice”) claim against a pharmacy and/or pharmacist, the pharmacist defendants are “barred from asserting the ‘seller shield’ defense set forth in the Tennessee Products Liability Act, Tenn. Code Ann. § 29-28-106.”

In Heaton v. Mathes, No. E2019-00493-COA-R9-CV (Tenn. Ct. App. April 3, 2020), plaintiffs filed an HCLA claim against several defendants based on complications suffered after using a certain prescription drug. The named defendants included the pharmacy and pharmacists who filled the prescription. According to plaintiff, his use of prescription Victoza resulted in pancreatitis. Plaintiff had begun using the drug in 2014, and approximately a year later the FDA issued a warning regarding the “risk of acute pancreatitis with the medication’s use.”

Regarding the pharmacy defendants, plaintiffs alleged that defendants “failed to provide any patient counseling to [plaintiff] related to risks associated with his continued use of Victoza.” Plaintiffs also asserted that the pharmacy defendants “failed to notify [plaintiff] of the 2015…warning, which noted the risk of developing acute pancreatitis with Victoza’s use[.]”

The pharmacy defendants filed a motion to dismiss based on the seller shield statute, part of the Tennessee Products Liability Act, which “provides that a products liability action cannot be maintained against a product’s seller, other than the manufacturer, except in certain enumerated circumstances.” Defendants argued that “the statute shielded pharmacists from liability in the situation alleged in the complaint,” and that plaintiffs’ “complaint mislabeled the alleged claims against the [pharmacy] defendants as health care liability claims when the gravamen of the complaint against the [pharmacy] defendants was a products liability claim.” Defendants asserted that “the TPLA…applies to failure-to-warn claims against pharmacists as sellers of drugs and, therefore, the claim should be dismissed based upon [the seller shield statute] because the [pharmacy] defendants were merely sellers and not the product’s manufacturers.”

The trial court ruled that the seller shield statute did not apply in this case because the claim fell under the HCLA and denied the motion to dismiss. The trial court and Court of Appeals granted an interlocutory appeal.

Under the Tennessee Rules of Appellate Procedure, the Court was constrained to consider only the question certified by the trial court, which was:

If the complaint asserts a claim under the Tennessee Health Care Liability Act against the pharmacy/pharmacist defendants, are the pharmacy/pharmacist defendants barred from asserting the “seller shield” defense set forth in the Tennessee Products Liability Act, Tenn. Code Ann. § 29-28-106?

Of note, the Court stated that based on this certified question, the trial court had determined that the pharmacy defendants “had conceded the applicability of the Health Care Liability Act to this cause of action.” Ultimately, the Court concluded that the seller shield defense could not be used here.

In its analysis, the Court noted that the applicability of the HCLA was widened in 2011 when the Tennessee Legislature changed the Medical Malpractice Act to the Health Care Liability Act. Under the broad definitions that are now part of the HCLA, “pharmacists and pharmacies clearly come within the THCLA’s definition of health care providers.”

The Court further noted that there had been no previous Tennessee cases “addressing the interplay between the THCLA and TPLA when there is an allegation that the medication itself was dangerous.” The issue had been addressed, however, by the Massachusetts federal district court in a case where a plaintiff claimed he received contaminated injections of a drug, with that court ultimately concluding that “the THCLA was the more specific statute between the two; therefore, the THCLA took precedence and rendered the TPLA inapplicable.”(internal citation omitted).

The Court of Appeals agreed with this analysis. The Court reasoned:

Based on the trial court’s determination and the [pharmacy] Defendants’ concession that the claims stated fall under the THCLA, we determine that the seller shield defense contained within the TPLA cannot apply. A natural and reasonable reading of the language of Tennessee Code Annotated § 29-28-106 demonstrates that it only applies to product liability actions. Furthermore, the THCLA applies to all health care providers, including pharmacies and pharmacists, without limitation based on any type of product seller immunity. The [pharmacy] defendants’ attempts to utilize the TPLA’s seller shield defense to immunize themselves from liability for a claim filed pursuant to the THCLA would be akin to an attempt by a defendant in a product liability action to defend on the basis of lack of pre-suit notice, which is a defense only to a claim under the THCLA.

The Court concluded that the seller shield could not be used in this HCLA case.

The Court came to the right result here. As it pointed out, using defenses contained in the Products Liability Act in an HCLA case would be tantamount to defending a product liability suit on the basis of a plaintiff’s failure to give pre-suit notice or a certificate of good faith.

NOTE: this opinion was released ten weeks after oral argument.

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